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Found 22 results
510(k) Data Aggregation
K Number
K243818Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Manufacturer
Hartalega NGC Sdn. Bhd.
Date Cleared
2025-01-08
(27 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
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K Number
K223437Device Name
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Manufacturer
Hartalega NGC SDN. BHD.
Date Cleared
2023-05-17
(184 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate (Fusion Colour) is a disposable single-use, non-sterile, fusion-colored and powder-free examination glove made from nitrile latex.
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K Number
K222225Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
Manufacturer
Hartalega NGC Sdn. Bhd.
Date Cleared
2022-11-11
(109 days)
Product Code
LZA, LZC, OPJ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) is a disposable singleuse, non-sterile, blue-colored and powder-free examination glove made from nitrile latex.
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K Number
K214074Device Name
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
Manufacturer
Hartalega NGC SDN. BHD.
Date Cleared
2022-05-26
(150 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Not Found
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K Number
K211758Device Name
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
Manufacturer
Hartalega Ngc Sdn. Bhd.
Date Cleared
2021-08-03
(57 days)
Product Code
OPC, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega Ngc Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 14.9 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 22.9 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes. Warning: Do not use with Carmustine Warning: Do not use with Thiotepa
Device Description
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
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K Number
K201772Device Name
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Manufacturer
Hartalega NGC Sdn. Bhd.
Date Cleared
2020-08-25
(57 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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K Number
K201530Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Manufacturer
Hartalega Ngc Sdn. Bhd.
Date Cleared
2020-08-05
(58 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega Ngc Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Dark Grey) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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K Number
K200581Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Manufacturer
Hartalega NGC SDN. BHD.
Date Cleared
2020-04-25
(51 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotheraty Drugs and Fentany Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Cliemotherapy Drugs and Fentanyl Citrate
Device Description
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Ask a Question
K Number
K200019Device Name
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Manufacturer
Hartalega NGC Sdn. Bhd.
Date Cleared
2020-04-06
(94 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Device Description
Not Found
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K Number
K192232Device Name
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Manufacturer
Hartalega NGC Sdn. Bhd.
Date Cleared
2019-11-08
(84 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) is a non-sterile disposable device intended for medical purposes that is worn on examiner's hand to protect contamination between patient and examiner
Device Description
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
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